Recall Z-2429-2020 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Suntech Medical, Inc.
Oscar 2, Model 250 System
| Date | Apr 20, 2020 |
| Status | Terminated |
| Reason | The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg. |
| Root cause | Process change control |
| Action | Suntech Medical Instruments, Inc. notified customers on about [DATE] via "URGENT: MEDICAL DEVICE RECALL" letter. Customers were informed that the device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg. Suntech Medical is instructing physicians and nurses that they can still use the device and are to ignore the readings on the device display and to continue to focus on the Accuwin Pro data for diagnosis. Best practice is to disable the device display during unit configuration and to |
| Quantity | 1,037 units |
| Distribution | Nationwide distribution to CA, CT, FL, IL, LA, MD, NC, NY, OH, PA, PR, SC, TN, TX, UT. Worldwide distribution to Australia, Austria, Belgium, Bermuda, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, Estonia, France, India, Ireland, Latvia, Lebanon, Morocco, Pakistan, Peru, Poland, Sa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151520 | Oscar 2 Suntech Medical, Inc., Feb 19, 2016 |